Department of Child and Adolescent Psychiatry and de Bascule, Academic Medical Center Amsterdam, Meibergdreef 5, Amsterdam, 1105, AZ, The Netherlands.
BMC Pediatr. 2012 Sep 25;12:156. doi: 10.1186/1471-2431-12-156.
Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children's competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents.
METHODS/DESIGN: In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130-190 subjects, providing a minimum of 10-15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment.
A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children's competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies.
目前，超过 50%的给儿童开的处方药物并没有在他们这个年龄段进行适当的评估。儿童被排除在临床试验之外的一个关键原因是，他们被认为无法对参与决定行使有意义的自主权。荷兰法律规定，12 岁及以上的人可以被推定为具有同意能力；然而，在儿科实践中，儿童的能力并不是那么明确，从同意到积极同意的转变是渐进的。儿童同意能力评估的黄金标准并不存在。在本文中，我们描述了一项关于开发一种标准化工具评估儿童和青少年参与研究的同意能力的研究方案。
方法/设计：在这项研究中，我们修改了 MacCAT-CR，这是评估成人同意能力的最佳评估工具，用于儿童和青少年。我们将前瞻性地在正在进行的临床试验的选择阶段对 6 至 18 岁的儿科患者进行测试。MacCAT-CR 访谈的结果将与参考标准进行比较，参考标准由临床研究者和一个由儿童精神科医生、儿童心理学家和医学伦理学家组成的专家小组确定。工具的可靠性、效标相关性和可重复性将被确定。由于 MacCAT-CR 是一个由 13 个项目组成的多项目量表，因此在 130-190 名受试者中进行了论证，每个项目至少有 10-15 个观察值。MacCAT-CR 的结果将与年龄、生活经验、智商、种族、社会经济地位和父母的同意判断相关联。预计在 2 年内将有 160 名参与者完成入组。
在研究实践中，特别是在儿童和青少年人群中，非常需要对同意能力评估工具进行有效性研究。在这项研究中，我们将建立一个儿童同意能力的参考标准，同时验证一个评估工具。研究结果可以通过进一步制定指南、医疗保健政策和法律政策，促进儿童在临床试验中的负责任参与。
